For over two decades, when assessing the propriety of a “natural”-type claim (e.g., “natural,” “all natural,” “100% natural,” “from nature,” “naturally grown,” or “naturally sourced”) made in food labeling, FDA has applied an informal definition set forth in the preamble to a final rule implementing the Nutrition Labeling and Education Act of 1990. See generally 58 Fed. Reg. 2302, 2407 (Jan. 6, 1993) (“natural” claims). Under this policy definition, FDA essentially has considered the term “natural” to mean that nothing artificial or synthetic (including all color additives regardless of source) has been included in, or has been added to, a food that would not normally be expected to be in that food.
Recently, FDA published a Federal Register notice, soliciting information and comments on the use of the term “natural” in food labeling, as a possible prelude to updating the legal status and substance of its definition. The agency notes, for example, that its present, informal definition does not address food production, processing and manufacturing methods, nor any nutritional or other health benefits, for a food described as “natural.”
FDA specifically asks for information and comments on the following questions:
- Should we define, through rulemaking, the term "natural?" Why or why not?
- Should we prohibit the term “natural” in food labeling? Why or why not?
- If we define the term “natural,” what types of food should be allowed to bear the term "natural?"
- Should only raw agricultural commodities be able to bear the term? Why or why not? Section 201(r) of the FD&C Act defines the term “raw agricultural commodity” as “any food in its raw or natural state, including all fruits that are washed, colored, or otherwise treated in their unpeeled natural form prior to marketing.”
- Should only single ingredient foods, e.g., bottled water or bagged spinach, be able to bear the term? Why or why not?
- If multi-ingredient foods should be able to bear the term, what type(s) of ingredients would disqualify the food from bearing the term? Please explain why such disqualification would be warranted.
- We are interested in any data or other information to suggest that consumers associate, confuse, or compare the term “natural” with “organic” (the USDA Agricultural Marketing Service administers the National Organic Program, which enforces laws and regulations regarding certified organic foods). We are interested in data and other information about consumers’ understanding of foods labeled “natural” versus “organic.” Is the term “natural” on food labels perceived by consumers the same way as “organic?" Or is “natural” perceived by consumers to be “better” (or not as good as) “organic?" Please provide consumer research or other evidence to support your comment.
- If we were to revise our policy regarding the use of the term “natural” or engage in rulemaking to establish a regulatory definition for “natural,” should certain production practices used in agriculture, for example, genetic engineering, mutagenesis, hybridization, the use of pesticides, or animal husbandry practices, be a factor in defining “natural?" Why or why not?
- We are interested in any data or other information to suggest that consumers associate, confuse, or compare the term “natural” with “healthy.” We have a regulation that defines the term “healthy” when used as an implied nutrient content claim with specific conditions related to the food’s nutrient profile that must be met in order to use the term on the label or in labeling of a food (see § 101.65(d)). We are interested in data and other information about consumers’ understanding of foods labeled “natural” versus “healthy.” Is the term “natural” on food labels perceived by consumers the same way as “healthy?" Or is “natural” perceived by consumers to be “better” (or not as good as) “healthy?" Do consumers view “natural” and “healthy” as synonymous terms? Please provide consumer research or other evidence to support your comment.
- Should manufacturing processes be considered in determining when a food can bear the term "natural?" For example, should food manufacturing processes, such as drying, salting, marinating, curing, freezing, canning, fermenting, pasteurizing, irradiating, or hydrolysis be a factor in defining "natural?"
- Should the term “natural” only apply to “unprocessed” foods? If so, how should “unprocessed” and “processed” be defined for purposes of bearing the claim? If the term natural should include some processing methods, what should those methods be? In making determinations related to processing, should one look at the process to make a single ingredient of a food, or does one evaluate the process done to the formulated finished food product (or both)?
- The current policy regarding use of the term "natural" hinges in part on the presence or absence of synthetic ingredients. For example, under the current policy, synthetic forms of vitamin D would not be used in a food claiming to be “natural,” whereas naturally sourced vitamin D (e.g., from salmon or egg yolks) could be. Should the manner in which an ingredient is produced or sourced affect whether a food containing that ingredient may be labeled as "natural?" Please explain your reasoning.
- What can be done to ensure that consumers have a consistent and accurate understanding of the term “natural” in food labeling to ensure that it is not misleading?
- What are the public health benefits, if any, of defining the term “natural” in food labeling? Please provide supporting data and other information to support your comment.
- Should “natural” have some nutritional benefit associated with it? If so, what should be the benefit? What nutrients should be considered? What data are available to support the association between “natural” and a given nutritional benefit, and/or between “natural” and certain nutrients?
- How might we determine whether foods labeled “natural” comply with any criteria for bearing the claim?
Information and comments responsive to these questions and/or related matters should be submitted to FDA by February 10, 2016.
FDA’s announcement is somewhat surprising given that the agency told three federal courts over the last few years that the agency “respectively declines” to come to an administrative determination of whether specific ingredients belong in foods labeled as “all natural.” “In a world of limited resources,” the agency said it had more pressing priorities relating to “public health and safety matters.”
What has changed? First, FDA's Center for Food Safety and Applied Nutrition has a new director, Dr. Susan Mayne. Second, the agency is well on its way to publishing final rules mandated by the FDA Food Safety Modernization Act and is possibly several months away from finalizing proposed rules revamping the Nutrition Facts panel.
The agency’s announcement, whether intentional or not, will have its most immediate impact on pending class action cases challenging “all natural” claims that have flooded the federal courts, particulary in the Northern District of California. Defense attorneys will be able to raise the primary jurisdiction defense with more gravitas than before. It is expected that at least some judges will issue stays.
But the primary jurisdiction defense is not a defense that will bring all class action cases over “natural” claims to a permanent halt. The defense will remain effective so long as FDA is actively working on the issue. Should FDA only collect comments and then let them "gather dust," courts may eventually lift any stays that were granted and allow plaintiffs to proceed with their cases against food companies under state consumer protection laws.
The U.S. Department of Agriculture, the National Advertising Division of the Council of Better Business Bureaus, and the Canadian government all have firm guidelines on “natural” claims for food. FDA could develop guidelines as well. That step would help remove class action cases challenging “natural” claims from the dockets of the federal courts once and for all.